Digestive Tolerance of Maltitol and FOS

Not Applicable

Completed

• Conditions: Digestive Tolerance in Healthy Adults
• Interventions: Other: maltitol 68% / FOS 32%; Other: maltitol 50% / FOS 50%; Other: FOS alone; Other: Placebo; Other: maltitol alone; Other: maltitol 85% / FOS15%

• Registration Number: NCT01909323
• Lead Sponsor: Syral

Brief Summary

Digestive symptoms following consumption of low digestibe carbohydrates are generally assessed product by product but several ingredients can be used simultaneously. The study aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-09
• Study Completion: 2012-11
• Status Verified: 2013-07
• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-25
• Last Update Submitted: 2013-07-25
• Study First Posted: 2013-07-26
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• BMI between 18.5 and 30
• normal and regular stool frequency: at least 3 stools per week and no more than 3 per days
• subjects not sufferinf from a metabolic, functional or inflammatory disease affecting intestinal transit and nutrients absorption
• subjects not sufferinf from IBS according to Rome III criteria
• subjects not using mdeiction which could affect nutrients absoprtion

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
maltitol 68% / FOS 32%	maltitol 68% / FOS 32%	-
maltitol 50% / FOS 50%	maltitol 50% / FOS 50%	-
FOS alone	FOS alone	-
sugary dessert cream	Placebo	-
maltitol alone	maltitol alone	-
maltitol 85% / FOS 15%	maltitol 85% / FOS15%	-

Primary Outcome Measures

Name	Time	Method
Composite score of gastrointestinal symptoms in the 24h following the consumption of products	24 hours

Secondary Outcome Measures

Name	Time	Method
Individual scores of gastrointestinal symptoms: bloating, abdominal discomfort, borborygms, flatulences	24 and 48 hours
Stool frequcency and consistency	24 & 48 hours
Glycaemic response	2 hours

Trial Locations

Locations (1)

Biofortis SAS; 🇫🇷 Saint-Herblain, France